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"Equistasi" and Gait in Hemiparesis

This study is currently recruiting participants.
Verified September 2016 by Ilaria Zivi, Ospedale Generale Di Zona Moriggia-Pelascini
Sponsor:
ClinicalTrials.gov Identifier:
NCT02714478
First Posted: March 21, 2016
Last Update Posted: September 30, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Ilaria Zivi, Ospedale Generale Di Zona Moriggia-Pelascini
  Purpose
The purpose of the study is to evaluate the effect of "Equistasi" device on quantitative and qualitative gait characteristics in patients affected by hemiparesis.

Condition Intervention Phase
Hemiparesis Device: equistasi Device: placebo Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy of "Equistasi" on the Gait of Patients Affected by Hemiparesis Due to Cerebrovascular Accident

Further study details as provided by Ilaria Zivi, Ospedale Generale Di Zona Moriggia-Pelascini:

Primary Outcome Measures:
  • disability change assessed using Functional Independence Measure scale [ Time Frame: 0. 30. 60. 120 days ]
  • balance change assessed using Berg Balance Scale [ Time Frame: 0. 30. 60. 120 days ]
  • gait pattern change assessed using Functional Ambulation Classification scale [ Time Frame: 0. 30. 60. 120 days ]
  • gait speed change assessed using Timed Up and Go scale [ Time Frame: 0. 30. 60. 120 days ]
  • gait pattern change using Tinetti scale for gait [ Time Frame: 0. 30. 60. 120 days ]
  • gait speed change assessed using 10 meter walking test scale [ Time Frame: 0. 30. 60. 120 days ]
  • swaying of the center of gravity change assessed with stabilometric platform indexes [ Time Frame: 0. 30. 60. 120 days ]

Estimated Enrollment: 50
Study Start Date: April 2015
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: treatment
3 "Equistasi" devices will be placed during physiotherapy, 5 times per week, for 4 weeks
Device: equistasi
3 devices will be placed in each patient: 1 at the spinosus process of L5; 1 at the insertion of transverse abdominis; 1 at the insertion of the gluteus medius to the femur. The devices will be kept for 55 minutes, during standard Physiotherapy
Placebo Comparator: controls
3 "placebo" devices will be placed during physiotherapy, 5 times per week, for 4 weeks
Device: placebo
3 devices will be placed in each patient: 1 at the spinosus process of L5; 1 at the insertion of transverse abdominis; 1 at the insertion of the gluteus medius to the femur. The devices will be kept for 55 minutes, during standard Physiotherapy

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • subacute hemiparesis
  • Functional Ambulation Classification <4

Exclusion Criteria:

  • previous neurological deficits
  • Glasgow Coma Scale <13
  • Complete sensory deficit in the lower limbs
  • Levels of Cognitive Functioning ≤5
  • polyneuropathy
  • contraindications to mobilization/verticalization
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02714478


Contacts
Contact: Giuseppe Frazzitta, MD +39033492705 frazzittag62@gmail.com

Locations
Italy
Department of Brain Injury and Parkinson Disease Rehabilitation, "Moriggia-Pelascini" Hospital Recruiting
Gravedona, CO, Italy, 22015
Contact: Giuseppe Frazzitta, MD    +39033492705    frazzittag62@gmail.com   
Sponsors and Collaborators
Ospedale Generale Di Zona Moriggia-Pelascini
  More Information

Responsible Party: Ilaria Zivi, MD, Ospedale Generale Di Zona Moriggia-Pelascini
ClinicalTrials.gov Identifier: NCT02714478     History of Changes
Other Study ID Numbers: Equistasi.01
First Submitted: March 10, 2016
First Posted: March 21, 2016
Last Update Posted: September 30, 2016
Last Verified: September 2016

Additional relevant MeSH terms:
Paresis
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms